Virvirilo 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Virvirilo 5 mg film-coated tablets EFG

Tadalafil

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Virvirilo is and what it is used for
2. What you need to know before taking Virvirilo
3. How to take Virvirilo
4. Possible adverse effects
5. How to store Virvirilo
6. Contents of the pack and other information

1. What Virvirilo is and what it is used for

Virvirilo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Virvirilo 5 mg is used for the treatment of adult men with:

• Erectile dysfunction. This occurs when a man cannot achieve or maintain a firm erection sufficient for satisfactory sexual activity. Virvirilo has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity. Following sexual stimulation, Virvirilo works by helping to relax the blood vessels in the penis, allowing blood to flow into it. The result is improved erectile function. Virvirilo will not help you if you do not have erectile dysfunction. It is important to warn you that Virvirilo is not effective in treating erectile dysfunction in the absence of sexual stimulation. Therefore, you and your partner must engage in sexual stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.
• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting urination, a sensation that the bladder has not emptied completely, and a need to urinate more frequently, even at night. Virvirilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Virvirilo has been shown to improve these urinary symptoms within as little as 1–2 weeks after starting treatment.

2. What you need to know before taking Virvirilo

Do not take Virvirilo if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).

• you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor (see section “Use of Virvirilo with other medicines”).

• you have a serious heart condition or have recently had a heart attack (within the last 90 days).

• you have recently had a stroke (within the last 6 months).

• you have low blood pressure or uncontrolled high blood pressure.

• you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".

• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Virvirilo.

Be aware that sexual activity carries a potential risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will perform a prostate cancer evaluation before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil cinfamed does not treat prostate cancer.

Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any deformity of the penis.
• a severe liver problem.
• a severe kidney problem.

It is not known whether tadalafil is effective in patients who have undergone:

• pelvic surgery.
• a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking Virvirilo, stop taking Virvirilo immediately and contact your doctor without delay.

Sudden decrease or loss of hearing has been observed in patients taking tadalafil. Although it is unknown whether these cases are directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking tadalafil cinfamed and contact your doctor immediately.

Virvirilo is not intended for use in women.

Children and adolescents

Virvirilo must not be used in children or adolescents under 18 years of age.

Use of Virvirilo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Virvirilo if you are already using nitrates (see “Do not take Virvirilo”).

Some medicines may be affected by Virvirilo or may affect how well tadalafil works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines for treating high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for treatment of fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Virvirilo with food and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect the way tadalafil cinfamed works and should be taken with caution. Consult your doctor for further information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testes was observed. In some men, reduced sperm count has been observed. These effects are unlikely to result in infertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Virvirilo contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Virvirilo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Virvirilo

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Virvirilo tablets are for oral use only in men. Swallow the tablet whole with a little water. The tablets may be taken with or without food.

Alcohol consumption may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness upon standing.

For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet once daily, taken at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to tadalafil. This will be achieved by taking a 2.5 mg tablet.

Do not take Virvirilo more than once a day.

Daily administration of Virvirilo may be beneficial for men who expect to have sexual activity two or more times per week. Daily Virvirilo allows you to achieve an erection at any time during the 24-hour day, provided that sexual stimulation is present.

It is important to inform you that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should engage in stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once daily, taken at approximately the same time each day.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once daily.

You must not take Virvirilo more than once a day.

If you take more Virvirilo than you should

Consult your doctor. You may experience adverse effects described in section 4.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Virvirilo

Take your dose as soon as you remember, but do not take a double dose to make up for missed doses. You must not take tadalafil cinfamed more than once a day.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. These effects are generally mild to moderate in intensity.

If you experience any of the following adverse effects, stop using the medicine and seek immediate medical help:

• allergic reactions including rashes (uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon).
• priapism, a prolonged and possibly painful erection after taking Virvirilo (rare frequency). If you experience this type of erection, which may last continuously for more than 4 hours, you must contact a doctor immediately.
• sudden vision loss (rare frequency), distorted, diminished, central blurred vision, or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

Common (observed in 1 to 10 out of every 100 patients)

• headache
• back pain
• muscle pain
• pain in arms and legs
• facial flushing
• nasal congestion
• indigestion

Uncommon (observed in 1 to 10 out of every 1,000 patients)

• dizziness
• stomach pain
• nausea
• vomiting
• reflux
• blurred vision
• eye pain
• difficulty breathing
• presence of blood in the urine
• prolonged erection
• palpitations, rapid pulse, high blood pressure, low blood pressure
• nosebleeds and tinnitus (ringing in the ears)
• swelling of the hands, feet or ankles, and feeling tired

Rare (observed in 1 to 10 out of every 10,000 patients)

• fainting
• seizures
• temporary memory loss
• eyelid swelling, red eyes, sudden partial or complete hearing loss, and urticaria (red, itchy skin rashes)
• penile bleeding
• blood in the semen
• increased sweating

Rare cases of myocardial infarction (heart attack) and stroke have also been reported in men taking Virvirilo. Most of these men had pre-existing heart problems before taking this medicine.

Rare cases of decreased or lost vision, either partial, temporary or permanent, in one or both eyes have also been reported.

Some additional rare adverse effects have been reported in men taking tadalafil that were not observed during clinical trials. These include:

• migraine
• facial swelling
• severe allergic reaction causing swelling of the face or throat
• severe skin rashes
• certain disorders affecting blood flow to the eyes
• irregular heartbeat
• angina pectoris
• sudden cardiac death
• distorted, diminished, central blurred vision or sudden decrease in vision (frequency not known)

In men over 75 years of age receiving treatment with Virvirilo, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving treatment with Virvirilo, the most frequently reported adverse effect was diarrhea.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Virvirilo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located in the pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Virvirilo

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are:

Tablet core: Lactose monohydrate, sodium lauryl sulfate, povidone, crospovidone type B and sodium stearyl fumarate.

Tablet coating: Polyvinyl alcohol, macrogol, titanium dioxide (E171), talc and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Virvirilo 5 mg is a yellowish-ochre, film-coated oval tablet, sized 8.1 mm x 4.1 mm, marked with "5" on one side and smooth on the other.

Virvirilo 5 mg is available in blister packs containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna 66-68-70. Polígono Industrial Urtinsa II.
28923 Alcorcón (Madrid)
Spain

Manufacturer

TEVA Pharmaceutical Industries, 18 Eli Hurvitz Street, Industrial Zone, Kfar-Saba 44102, ISRAEL
TEVA PHARMA, S.L.U. Polígono Industrial Malpica, C/C, nº4
50016, Zaragoza, SPAIN

Date of the most recent revision of this leaflet: November 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es